Key result
The article discusses moving from substantial equivalence to substantial improvement for 510(k) medical devices.
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Advocates reevaluating 510(k) standards toward demonstrated improvement; leaves open effects on innovation and patient access.
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Redberg et al. (2019) conducted an editorial in Medical devices (510(k) pathway). 510(k) device regulation was evaluated. The article discusses moving from substantial equivalence to substantial improvement for 510(k) medical devices.
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